Response and Remediation
US FDA Response and Remediation
We help clients with their response and remediation of 483s, Warning Letters, and Consent Decrees. Exemplar Compliance understands that the success or failure of your FDA remediation effort directly impacts your business and your financial future. We equip you with former FDA and Industry Experts who provide insight and hands-on experience. We work with your management team to evaluate current quality and compliance risks and implement effective solutions that make sense for your business. Additionally, we assist with the preparation of FDA responses that implement corrective actions based on science and data.
Our team has a broad understand of regulatory expectations and an extensive background in FDA remediation.
Exemplar Compliance works with your organization to provide:
- Remediation solutions focused on FDA regulations and guidance documents.
- A cooperative working environment where we educate clients.
- Scientifically based response plans.
- Quality investigations and CAPA.
- Remediation of procedures, work instructions, and training
- Project Management for site/corporate FDA remediation activities
Remediation Outside of the US
Do you need assistance with response or remediation for products marketed outside of the United States? We perform gap assessment and remediation activities for numerous regions outside of the US including:
- Japan – MHLW
- China – SFDA
- Brazil – ANVISA
- Canada – Health Canada
- Europe – EMEA
- UK – MHRA
- Australia – TGA